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Oncology Newsfeed

  • FDA Approves Bevacizumab-maly Biosimilar for Colorectal Cancer

    On Monday, April 18, 2022, the U.S. Food and Drug Administration (FDA) approved Alymsys® (bevacizumab-maly), a biosimilar to Avastin® (bevacizumab). Alymsys' approved indications include:

    • Metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment

    • Metastatic colorectal cancer in combination with fluoropyrimidine-irinotecan- or fluoropyrimidineoxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.

    Read Brand Institute's announcement for more information.

    Posted 4/18/2022



  • Secretary of HHS Extends COVID-19 Public Health Emergency

    Effective April 16, 2022, Secretary of Health and Human Services (HHS) Xavier Becerra renewed the COVID-19 public health emergency that has existed nationwide since January 27, 2020.

    For more information, visit the HSS website.

    Posted 4/14/2022



  • FDA Approves Axicabtagene Ciloleucel for Large B-Cell Lymphoma

    On Friday, April 1, 2022, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.

    Read the FDA announcement.

    Read Gilead's announcement.

    Posted 4/4/2022


  • FDA Approves Lutetium Lu 177 Vipivotide Tetraxetan for Prostate Cancer

    On March 23, 2022, the U.S. Food and Drug Administration (FDA) approved lutetium Lu 177 vipivotide tetraxetan for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. 

    Read the FDA announcement.

    Read Novartis' announcement.

    Posted 3/24/2022



  • FDA Approves Pembrolizumab for Advanced Endometrial Carcinoma

    On March 21, 2022, the U.S. Food and Drug Administration (FDA) approved pembrolizumab as a single agent for patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.

    Read the FDA announcement.

    Read Merck's announcement.

    Posted 3/22/2022


  • FDA approves nivolumab and relatlimab-rmbw for melanoma

    On March 18, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab and relatlimab-rmbw for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

    Read the FDA announcement.

    Read Bristol Myers Squibb's announcement.

    Posted 3/21/2022


  • FDA Approves FoundationOne®CDx in Non-Small Cell Lung Cancer

    On Thursday, March 17, 2022, the U.S. Food and Drug Administration (FDA) approved the FoundationOne®CDx to be used as a companion diagnostic to identify patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) alterations and are appropriate for treatment with EGFR tyrosine kinase inhibitors that are approved by FDA for this indication.

    Read Foundation Medicine's announcement.

    Posted 3/17/2022


  • FDA Approves BRACAnalysis® CDx in Early-Stage Breast Cancer

    On March 11, 2022, the U.S. Food and Drug Administration (FDA) approved Myriad Genetics, Inc.'s BRACAnalysis® CDx test for use as a companion diagnostic to identify patients with germline BRCA-mutated (gRBCAm) human epidermal growth factor receptor 2 (HER2)-negative, high-risk, early-stage breast cancer who may benefit from Lynparza® (olaparib) (AstraZeneca).

    Read the Myriad Genetics, Inc. announcement.

    Posted 3/14/2022



  • FDA Approves Olaparib for High-Risk Early Breast Cancer

    On Friday, March 11, 2022, the U.S. Food and Drug Administration (FDA) approved olaparib for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative, high-risk, early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.

    Read the FDA announcement.

    Read AstraZeneca's announcement.

    Posted 3/14/2022


  • FDA Approves Nivolumab in Combination for Early-Stage NSCLC

    On Friday, March 4, 2022, the U.S. Food and Drug Administration approved nivolumab with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting.

    Read the FDA announcement.

    Read Bristol Myers Squibb's announcement.

    Posted 3/7/2022